Senior Director, Business Operations and Clinical OutsourcingWaltham, Massachusetts
At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health.
Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera's mission to advance novel therapies for obesity and related conditions.
We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence.
As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.
What You'll Do: The Senior Director, Business Operations and Clinical Outsourcing is a strategic leadership role within the Development organization, dedicated to driving operational excellence across Clinical Development Operations.
This role focuses on designing and optimizing business processes to ensure regulatory compliance, operational efficiency, and scalability to support the company's growth.
With oversight spanning clinical compliance, technology systems, and vendor partnerships, this individual will play a key role in shaping the company's clinical trial operations and building capabilities to meet future portfolio demands.
Responsibilities: Establish a Center of Excellence (COE) for strategic outsourcing to support the development of innovative obesity therapies.Collaborate with the Clinical Development Operations and other stakeholders to forecast and manage expenditures for Kailera's clinical programs.Provide data-driven recommendations through metrics, KPIs, and market analytics of study performance to senior leadership.Partner with Finance to manage the budget and cost management across Clinical Development Operations in alignment with Kailera's annual budget and long-range plan (LRP).Implement robust outsourcing strategies to advance Kailera's lead program, KAI-9531, and other pipeline assets.Manage end-to-end RFx (RFI/RFP) processes, supplier evaluations, and vendor negotiations with a focus on metabolic disease expertise.Oversee vendor transitions for clinical trials, ensuring operational continuity and cost efficiency.Develop and manage governance structures to maintain transparency, accountability, and compliance with regulatory standards.Build and maintain strategic partnerships with CROs and service providers specializing in obesity and related therapeutic areas.Lead negotiations and execute agreements, budgets, payment terms, and change orders to optimize vendor relationships.Drive cost savings through innovative sourcing strategies and preferred partnership models.Drive a culture of innovation and operational excellence, ensuring the clinical operations function remains at the forefront of industry best practices and emerging trends.Collaborate with IT and other cross-functional leaders to proactively develop fit-for-purpose strategies (build vs. buy) and scalable processes and solutions that enable consistent, timely, and efficient delivery of the portfolio.Oversee the selection, implementation, and management of key clinical technologies (e.g., eTMF, EDC, ePro, eConsent, Cloud/SaaS, etc.
), ensuring compliance with regulatory requirements and integration into portfolio-level study execution.Inspire and mentor a team of outsourcing and procurement managers to foster professional growth and excellence.Cultivate a collaborative, innovative, and results-driven culture aligned with Kailera's core values.Required Qualifications: 12+ years of experience in business operations and clinical outsourcing, including leadership roles.Proven leadership experience in business operations, strategic sourcing, and clinical outsourcing within the pharmaceutical or biotechnology industries.Expertise in clinical trial outsourcing, with a strong preference for experience in obesity or metabolic disease treatments.Comprehensive knowledge of vendor management, financial modeling, and clinical trial operations (Phase 1–3).Exceptional negotiation, analytical, and decision-making skills.Experience with technology implementation and operational transformation within clinical trials.Ability to lead and inspire cross-functional teams and external partners in a collaborative environment.Deep understanding of clinical trial processes, vendor management, and regulatory requirements (e.g., ICH-GCP, 21 CFR Part 11).Strong communication and presentation skills, with experience engaging executive leadership.Education: Bachelor's degree in business administration, life sciences, or a related field; advanced degree (MBA, MS) preferred.Benefits of Working at Kailera: Comprehensive health benefits and tax-advantaged savings accounts.Flexible time off, 13 paid holidays, and a companywide year-end shutdown.Monthly wellness stipend.Generous 401(k) match.Disability and life insurance.At Kailera, we are committed to fostering an inclusive culture.
How we treat our people is reflective of this commitment.
We share the pay range for this particular role with the actual base salary depending upon factors such as job-related knowledge, skills, market factors, and experience.
Salary Range: $210,000 - $270,000 USD
EQUAL EMPLOYMENT OPPORTUNITY INFORMATION: Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age (40 and over), sex or gender, gender identity or expression, sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.
E-Verify: Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.
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